Biocon launches denosumab biosimilars in US market

Biocon Limited (BSE: 532523, NSE: BIOCON) announced the commercial launch of two denosumab biosimilar products in the United States. The company launched Bosaya and Aukelso, both denosumab-kyqq products, following U.S. Food and Drug Administration approval in September 2025 with interchangeable designation.

Bosaya serves as a biosimilar to Prolia for treating osteoporosis, while Aukelso functions as a biosimilar to Xgeva for bone complications associated with cancer. Both products are available nationwide through specialty pharmacies and healthcare providers by prescription.

The interchangeable designation allows pharmacy-level substitution in accordance with state laws. Denosumab products generated approximately $5 billion in U.S. sales in 2024, according to the company's press release.

The treatments target conditions affecting significant patient populations. Approximately 10 million adults in the United States have osteoporosis, with an additional 44 million at risk due to low bone density. Bone metastases, a cancer complication, affect more than 330,000 patients annually in the country.

Bosaya is available as a 60 mg/mL injection for subcutaneous use in a prefilled syringe. Aukelso comes as a 120 mg/1.7 mL injection for subcutaneous use in a single-dose vial.

Both products carry warnings about severe hypocalcemia risks, particularly in patients with advanced kidney disease. Other warnings include potential hypersensitivity reactions, osteonecrosis of the jaw, and atypical femoral fractures.

Biocon operates in more than 120 countries and has commercialized 12 biosimilar products and over 30 generic formulations globally. The Bengaluru-based company maintains seven manufacturing sites, three research and development sites, and 18 offices worldwide.

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